“The Bar Has Been Raised” – CFSAC Spring 2013, Day One

The CFS Advisory Committee (CFSAC) provides advice and recommendations to the Secretary of Health and Human Services (HHS), through the Assistant Secretary for Health, on issues related to myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). The committee meets twice a year, and the Spring 2013 committee met on May 22-23 in Washington D.C. As usual, the meeting was streamed live over the internet, and video will be available on the CFSAC website in due course. The agenda for this meeting can be viewed here, and the roster of committee members is here.

This article describes Day One of the meeting. A packed program featured the brief return of former CFSAC Chair Wanda Jones, the welcome of three new ‘liaison representatives’ from patient organizations, agency updates from the CDC, CMS, HRSA and SSA, an hour of public comment, discussion of the committee’s controversial new ‘Prioritized Recommendations’, a valuable presentation on the forthcoming changes to Medicare, public and panel question and answer sessions, and a discussion of the new requirements for the committee to provide evidence in support of its recommendations.

Those new requirements for supporting documentation, which have come down to all the health committees from the Secretary of Health, were introduced right from the start of the day, and provoked discussion throughout the meeting as the committee members absorbed the implications of what seems like a significant change. In the end, the reality seems to be that these changes are coming, like it or not, and the challenge to the committee is clear: in order to be effective in getting its recommendations through it is going to have to raise its game. Read on to find out how CFSAC began its response to this new challenge…

Wanda Returns

The meeting began on a positive note, with the welcome return of the popular former CFSAC chair Wanda Jones, now Principal Deputy Assistant Secretary for Health at the US Department of Health and Human Services (DHHS). Wanda told the committee that she sees real change happening within the DHHS, and thinks the work of CFSAC has been key in driving that change. She admitted that change is never fast in government, and it is particularly difficult in today’s tough economic climate, but nevertheless she thinks things are moving forward.

She welcomed the new organizational representatives to CFSAC, and described a departmental overhaul of processes relating to the health advisory committees: there are more than 270 of them, which gives some indication of how much time the Secretary can spend reviewing the outputs of each one. Committees are now being asked to provide supporting evidence for their recommendations, and some committees are now meeting for 3-4 days and preparing white papers. Wanda said that this new model – which is coming down direct from the Secretary of Health – represents an ‘inflection point’ and a ‘new paradigm’, and offers an opportunity for recommendations to be taken up and acted upon. All these changes, she said, “give us the opportunity to improve collaboration and co-operation across the department”.

Reflecting on recent initiatives relating to ME/CFS across the department, Wanda was upbeat. The FDA Workshop had been “very positive and productive” and she “could not be more excited” about what the FDA can do. She saw other “extraordinarily exciting” developments too, particularly in the vast amount of information being developed from the CDC multi-site study: “The promise of those early findings is just phenomenal”. She feels the department is now moving forwards towards a research-based case definition and evidence-based methodology, and sees a tremendous opportunity here, which CFSAC’s work in the last 5-7 years has been key in creating.

Regrettably, Wanda then had to leave: her car was waiting. Although many of us miss Wanda’s presence and leadership at CFSAC, it’s good to know that she is in a position of influence within the DHHS and is able to represent the interests of ME/CFS patients in that new role. The trust and respect that Wanda has built up within the patient community should give us all hope when she tells us that from where she’s now sitting, she sees so many signs of exciting and positive changes and opportunities. Nevertheless, quite clearly that sense of optimism is not shared by all…

Welcome to the Jungle

CFSAC Chair Gailen Marshall began his opening remarks by welcoming the new committee members. Rebecca Collier, an ‘incredibly experienced case manager’, was introduced, but (unless I missed it) she did not speak for the remainder of the meeting – perhaps she’s wise to take some time to ‘get the lay of the land’! The new ‘liaison representatives’ of patient organizations were more active, and briefly introduced their organizations.

Kim McCleary, representing the CFIDS Association of America (CAA) noted that she had attended every committee meeting except one since September 1993 (when it was known as the ‘CFS co-ordinating committee’); the CAA, she said, had been “at the leading edge of ME/CFS research for more than 25 years”. Fred Friedberg, President of the International Association for CFS/ME (IACFS/ME), said that the 3 organizations represent a broad array of concerns and will help enlarge the recommendations of the committee. “It’s all to the good to have the three of us here today”. The New Jersey CFS Association (NJCFSA) were represented by Ken Friedman, who introduced the NJCFSA as a state-wide, all-volunteer organization, supporting patients and families, disseminating reliable information, and promoting research. He told the committee that they offer support groups, a helpline, website, facebook page, journal, research funding, advocacy, and much more besides, serving as a model for programs in other states.

Marshall then went on to set out how he wanted the committee to function. His email address, he said, is ‘widely available’, and he hopes that the committee – with its diverse perspectives – will go about its business in a ‘collegial and cordial’ manner, and be ‘efficient and effective’. He added that, ‘wherever we can, we want to seek a consensus’, and ‘when we don’t get that, we have to learn to agree to disagree’. That doesn’t mean 6-5 majority verdicts, he explained: it means that further information and discussion may be necessary. The aim, he explained, is to make recommendations that improve the lot of patients. And he added that he was going to try harder to keep the committee to time, emphasizing the importance of letting people speak, letting them finish (within the 3-minute timeframe for comment that he laid down), and ‘staying on task’.

In response to a question from Kim McCleary, Marshall clarified that the liaison representatives and ex-officios were also free to participate in CFSAC’s sub-committees.

Agency Updates

The agency updates section was relatively brief, with further questions to the ex-officio representatives addressed later in the meeting.

For the Centers for Disease Control (CDC), Ermias Belay presented the results of the first MedScape Roundtable Spotlight CFS CME/CE, a Continuing Medical Education program. Over 25,000 learners including 7,803 primary care phycisians and 8,082 nurses had viewed the 30-minute video roundtable discussion on “CFS: Challenges in Primary Care”. The new Medscape Roundtable, featuring Drs Anthony Komaroff, Lisa Corbin, Benjamin Natelson and Peter Rowe, was launched May 4, 2013, targeting primary care physicians using MedScape subscribers. Additional educational initiatives listed were a Medscape CDC ‘Expert Commentary’ – “Back to School and Chronic Fatigue Syndrome”; a Spanish translation of the CDC’s main CFS web page; a new pediatric/adolescent CFS section; and a medical student educational initiative, planned for MedEd Portal, with videos, slides and curriculum now ready for CDC clearance and MedEd Portal Peer Review.

Belay also outlined the CDC’s major multi-site study. Its objectives: to capitalize on the clinical expertise of physicians experienced in care and treatment of CFS patients, collect standardized data on major illness domains of CFS from patients in their practices, describe the heterogeneity of CFS patients between the practices, and use evidence-based data to address the problem of case definition and CFS subgroups. The clinics of Drs Natelson, Klimas, Bateman, Lapp, Kogelnik, Podell and Peterson are participating in the study. Results of the interim analysis were presented at the FDA Drug Development Workshop, indicating the heterogeneity of the CFS population both as a whole and between clinics. Stage 2 of the study will feature follow-up of the patients enrolled in Stage 1, with measurement of saliva for morning cortisol profile and blood for DNA and RNA, as well as additional studies at some clinics including cognition and exercise testing. IRB approval for the follow-up protocol was received May 2013; the protocols for pediatric, cognition and exercise testing are in development. (Read about the FDA workshops Day One here and Day Two here and here.)

Finally, Belay presented the Advocacy Group Collaboration work: the CFS Patient Centered Outreach and Communication Activity (PCOCA), a one-hour conference call, with a second call Jan 14, 2013 including Nancy Klimas and Connie Sol: “Redefining Exercise in CFS through Reconstruction of Aerobic Capacity”. Consultation about the content for the Pediatric/Adolescent CFS section was ongoing.

In a very short period of questioning, Kim McCleary asked whether the CDC intended to make the raw data from the multi-site study available to the public through RCDC. That would be a long process, said Belay, and the CDC would have to analyse it themselves first, but “eventually in future we’ll consider that”. Ken Friedman said that he personally believed the ‘trained trainer’ approach is more effective than online training, and asked whether the CDC had any evidence of increased effectiveness of diagnosis or treatment due to the program. Belay answered that such evidence would be extremely difficult to collect, but it was possible to measure how much the participants had understood through comprehension tests.

Speaking for the Center for Medicare & Medicaid Services (CMS), Alaine Perry was very brief because the agency had two speakers later on in the meeting. CMS, she explained, runs Medicare and federal Medicaid, and now has a new role with the Affordable Care Act to implement the new health insurance marketplace, regulate the private insurance market, and inform consumers about their new rights, options and protections. More information is available on healthcare.gov. Perry highlighted a major new funding opportunity in Healthcare Innovations Awards Round 2: up to $1bn is being spent on testing new payment delivery models, and in particular, on new models that improve care for populations with specialized needs. For more information, see cms.gov and click on ‘CMS Innovation Center’.

For the Health Resources and Services Administration (HRSA), Deborah Willis-Fillinger explained that the HRSA is responsible for access to healthcare activities, with an $8.5m budget. Its healthcare program has been expanding, supporting 8500 health centers across the country, targeted at under-served communities. She highlighted two new funding programs for integrative medicine. Asked whether the HRSA was still teaming up with the CDC to send out 17,000 paper copies of the toolkit, she replied that they were not, and were looking at ways to become more efficient .

For the Social Security Administration (SSA), Amanda Wulf had nothing to add to her comprehensive update at the previous CFSAC meeting; their current CFS/ME policy is on their site at socialsecurity.govand if there are any updates they will inform the committee.